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Last Updated: October 26, 2021

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Lenalidomide - Generic Drug Details

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What are the generic drug sources for lenalidomide and what is the scope of freedom to operate?

Lenalidomide is the generic ingredient in two branded drugs marketed by Arrow Intl and Celgene, and is included in two NDAs. There are fifteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has three hundred and seventy-six patent family members in forty countries.

There are fourteen drug master file entries for lenalidomide. One supplier is listed for this compound. There are three tentative approvals for this compound.

Recent Clinical Trials for lenalidomide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Juan DuPhase 2
Marcelo Pasquini, MDPhase 2
ADC Therapeutics S.A.Phase 1

See all lenalidomide clinical trials

Generic filers with tentative approvals for LENALIDOMIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial15MGCAPSULE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial10MGCAPSULE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial5MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lenalidomide
Paragraph IV (Patent) Challenges for LENALIDOMIDE
Tradename Dosage Ingredient NDA Submissiondate
REVLIMID CAPSULE;ORAL lenalidomide 021880 2016-07-12
REVLIMID CAPSULE;ORAL lenalidomide 021880 2010-08-30
REVLIMID CAPSULE;ORAL lenalidomide 021880 2010-07-12

US Patents and Regulatory Information for lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lenalidomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 5/2015 Austria ⤷  Free Forever Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294 SPC/GB07/047 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
2105135 CA 2015 00006 Denmark ⤷  Free Forever Trial PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
2105135 00140 Estonia ⤷  Free Forever Trial
2105135 92642 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Merck
Boehringer Ingelheim
McKesson
Medtronic

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